Healthcare systems

The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.

Novartis core operating income rose 10% at constant exchange rates in Q3 2026, and 2026 guidance for the measure was raised. #SyenzaNews #MarketAccess

A Pretoria court has declared invalid the antiretroviral tender awards for two items and ordered the health department to redo the split within 120 days. Cipla's review succeeded on all five grounds, while Hetero's challenge was dismissed with attorney-and-client costs. #SyenzaNews #SouthAfrica #HIV

Health security in Europe is being redefined from emergency response to national resilience, and the EFPIA View argues it starts with funded health systems.

Ministers, development banks and industry at the World Health Summit argued that health investment returns should be measured in lives saved, jobs and tax revenue, not budget size. #SyenzaNews #HealthEconomics #MarketAccess

At the World Health Summit in Berlin, speakers from the European Commission, Japan, Africa, the Asian Development Bank and industry argued that health is a strategic economic asset, and asked how to persuade finance ministries. #SyenzaNews #HealthEconomics

PhRMA has sued HHS and CMS over the GLOBE rule, arguing the agency has no authority to tie Medicare Part B drug payments to the prices paid in 19 other countries. The complaint leans on the major questions doctrine and a statutory ban on quality-adjusted life years. #SyenzaNews #MarketAccess #pharmaceuticals #healthcarepolicy #drugpricing

Lundbeck is trading scale for depth. Michala Fischer-Hansen, EVP for Europe and international markets, explains why 51 affiliates became 22, why a fifth of revenue now goes to R&D, and why US price pressure can decide where a medicine launches. #SyenzaNews #MarketAccess #brainhealth #pharma

US group health plans and issuers must rebuild their public price files under the Transparency in Coverage final rule: quarterly publication, an 11-claim threshold for out-of-network data, a new utilization file and attestation, and consumer phone disclosure from January 2027. #SyenzaNews #MarketAccess #PriceTransparency #HEOR

Alec Morton of NUS explains how AI is changing health technology assessment, what stays human, and why cheaper analysis could mean more health economics.

CTS's Global Horizon panel brought four US operators to Montréal to explain why the US healthcare market rewards commercial readiness over good technology, and what founders can do about it. #SyenzaNews #MarketAccess #HealthTech

South Korea is putting AI at the centre of its healthcare agenda, pairing the new AI Basic Healthcare Strategy with a USD 30.4 billion biohealth export target. Vice Minister Lee Hyung Hoon sets out the vision in an interview with PharmaBoardroom. #SyenzaNews #SouthKorea #Biohealth #DigitalHealth #MarketAccess